Clinical Research Directory

Pneumonia After Cardiovascular Surgery With an Artificial Intelligence

This multicenter, prospective, observational study aims to address two primary objectives. The first objective is to demonstrate that hospital-acquired pneumonia (nosocomial pneumonia) following cardiac surgery can be predicted using artificial intelligence (AI), and to develop a personalized risk calculator for its development. The second objective is to demonstrate that hospital-acquired pneumonia can serve as a risk factor for a 1-year composite cardiovascular and pulmonary outcome after cardiac surgery, and to develop a personalized risk calculator for this composite outcome. The composite outcome will include the occurrence of any of the following events: * Respiratory death * Hospitalization for respiratory diseases * Development of oxygen dependence * New-onset asthma, COPD, or interstitial lung disease * Initiation or intensification of bronchodilator or corticosteroid therapy * Cardiovascular death * Acute myocardial infarction * Unstable angina * Myocardial revascularization * Acute ischemic stroke * Transient ischemic attack * Acute heart failure * Hospitalization for decompensated heart failure * New-onset atrial fibrillation or ventricular tachycardia * Initiation or intensification of antiarrhythmic therapy Both objectives will be addressed using artificial intelligence technologies applied during the data analysis phase. This is a non-interventional study. Patient evaluation and treatment are conducted in strict accordance with approved standards of medical care for the respective conditions. No experimental or unregistered (not approved for use in the Russian Federation) medical or diagnostic procedures will be performed during this study.

Predictors and Outcomes of Ventilated Hospital-acquired Pneumonia

Hospital-acquired pneumonia (HAP) is defined as an infection of the pulmonary parenchyma that develops in patients admitted to hospital for more than 48 hours and that was not incubating at the time of admission. It represents one of the most common and serious nosocomial infections, associated with significant morbidity, prolonged hospitalisation, and increased mortality in critically ill patients. The aetiology of HAP is primarily driven by micro-aspiration of bacteria colonising the oropharynx and upper gastrointestinal tract. Pathogen distribution is shaped by the duration of hospitalisation, prior antibiotic exposure, local epidemiology, and patient characteristics. Multidrug-resistant (MDR) organisms are particularly prevalent in patients with prolonged inpatient stay and intensive care unit (ICU) admission, as critically ill patients become rapidly colonised with nosocomial pathogens. Ventilator-associated pneumonia (VAP), a subgroup of nosocomial pneumonia, occurs in patients requiring tracheal intubation and mechanical ventilation for at least 48 hours. A clinically important and increasingly recognised entity is ventilated HAP (v-HAP), defined as HAP that subsequently requires tracheal intubation and mechanical ventilation. Emerging evidence indicates that v-HAP carries the highest mortality among nosocomial pneumonia subtypes in ICU patients - exceeding VAP - while non-ventilated ICU-acquired HAP carries the lowest mortality.

Dexamethasone for Treating Severe Hospital-acquired Pneumonia in Critically Ill Patients With a Proinflammatory Phenotype

Determine the efficacy of dexamethasone plus standard of care (SOC) as compared to placebo plus SOC for treating severe hospital-acquired pneumonia in critically ill patients with a proinflammatory phenotype; It's an international phase III, double-blind, placebo-controlled, randomized trial.

Pneumonia Pathogens' Virulence Factors, Patient Inflammatory Markers, and Their Associations With Outcomes

The study aims to evaluate pneumonia symptoms using physical examinations, radiological and laboratory tests, and prognostic scales such as the Pneumonia Severity Index (PSI) and CURB65. These methods will be combined with the assessment of biomarkers and inflammatory cytokines to enhance clinical decision-making and predict adverse outcomes. Procalcitonin (PCT) levels will help guide the initiation and duration of antibiotic therapy, while variations in treatment may be based on initial levels of inflammatory biomarkers. A notable focus is placed on the CD64 marker, which can increase significantly under the influence of pro-inflammatory cytokines (IL-6, G-CSF) within hours and return to baseline as the infection subsides. Microbiological testing will be performed selectively, particularly when results could affect antimicrobial therapy choices. Sputum microscopy is planned before antibiotic prescription, with only high-quality samples being considered. Poor-quality sputum will not be further tested. Invasive diagnostic methods will be used only as specified by pneumonia treatment protocols. Bronchoscopy, including bronchoalveolar lavage (BAL), is reserved for severe pneumonia cases under specific conditions, such as failure to expectorate sputum, multiple Gram-negative or fungal isolates, or poor treatment response. Radiological diagnostics will include chest X-rays in anteroposterior and lateral views, as infiltrates in certain lung segments may be missed on single views. Early radiographic findings may reveal only subtle changes in the lung pattern, so follow-up imaging is planned to ensure an accurate diagnosis. The study will be conducted exclusively in specialized hospital units to maintain patient safety. The collected data will allow for the analysis of relationships between pathogens, their virulence, immune responses, and disease outcomes.